MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 40MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45040
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the subject stent was being deployed during the procedure, it became twisted in the mid portion.The device was replaced and the procedure was completed with no clinical consequences to the patient.
Additional Manufacturer Narrative
Device is not available for evaluation.
Additional Manufacturer Narrative
H4 manufacturing date added.D4 expiration date added.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.It was reported that the subject stent twisted (bow-tied in the mid portion of the stent) upon deployment.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use and was prepared as per the dfu, continuous flush was maintained for the duration of the procedure, the anatomy was tortuous, a microcatheter was used to deploy the device, no excessive force was applied at any point while advancing the stent within the microcatheter, and the stent size was appropriate for the treatment site.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.H3 other text : device is not available for evaluation.
Event or Problem Description
It was reported that when the subject stent was being deployed during the procedure, it became twisted in the mid portion.The device was replaced and the procedure was completed with no clinical consequences to the patient.

• Brand Name: SURPASS EVOLVE 4.5MM X 40MM - PMAS
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 12992640
• Report Number: 3008881809-2021-00524
• Device Sequence Number: 12081034
• Product Code: OUT
• UDI-Device Identifier: 07613327375282
• UDI-Public: 07613327375282
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: FDS45040
• Device Catalogue Number: FDS45040
• Device Lot Number: 2262267
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 12/14/2021
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female